Nextra Hammertoe Correction System-4.5MM Middle, 3.2MM Proximal, SS, Sterile. REF: NX-4532K - Product Usage: The Nextra Hammertoe Correction System is a system of implants and associated instruments which is indicated for small bone reconstruction limited to inter-digital repair and fusion of the lesser toes.
FDA Recall Z-1458-2020 · Posted 2020-02-24
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Recalling FirmNextremity Solutions
Recall StatusTerminated
Product CodeHWC
Date Initiated2020-02-12
Date Terminated2020-12-17
Product Quantity190 units
Reason for Recall
Proximal end of the driver in the affected product may be oversized in varying degrees, potentially making it difficult to connect with and remove from the proximal Nextra implant
Firm Action
Nextremity notified European distributors and customers of the FSCA via a Field Safety Notice dated 2/12/2020.The Field Safety Notice instructed return of all product with the specified lot number.
Root Cause
Under Investigation by firm
Distribution Pattern
International distribution in the countries of Spain, United Kingdom, Germany, and Switzerland.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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